Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Status and phase

Completed

Phase 2

Phase 1

Conditions

Idiopathic Pulmonary Fibrosis

Interstitial Lung Disease

Idiopathic Interstitial Pneumonia

Treatments

Drug: Bone marrow mesenchymal stem cells

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02594839

ILD-01

Details and patient eligibility

About

The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.

Full description

Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.

Enrollment

20 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients 20-80 years old
Diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on:
- Clinical symptoms > 12 months duration,
- Histologically diagnosed or diagnostic chest HRCT features of interstitial pneumonia
Forced Vital Capacity (FVC) ≥ 40% predicted and Diffusing Lung Capacity (DLCO) ≥20%
Loss more than 10% of FVC (L) and DLCO during the last 12 months
Signed informed consent.

Exclusion criteria

Diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc)
Obstructive lung disease: FEV1/FVC < 0.70
Clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study
Evidence of active infection within 4 week prior to enrollment
History of malignancy < 5 years prior to enrollment
Unable to cooperate with any study procedures
Pregnant or breast-feeding
Treatment with antiinflammatory or antifibrotic drugs including oral steroids, cytostatic drugs, pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib, interferon γ, monoclonal antibodies < 6 months prior to randomization.
Active listing for transplant of any organ.
Known history of alcohol abuse within 1 year prior to enrollment
Participation in another clinical trial